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Completed

NCT Number: NCT02817074

MIND Diet Intervention and Cognitive Decline

Phase III randomized controlled trial designed to test the effects of a 3-year intervention of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive decline and brain neurodegeneration among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets.

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Key information

Conditions

Cognitive Decline Alzheimer Disease Arterial Occlusive Diseases Arteriosclerosis Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Cognition Disorders Cognitive Dysfunction Dementia Dementia, Vascular Intracranial Arterial Diseases Intracranial Arteriosclerosis Leukoencephalopathies Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies Vascular Dementia Vascular Diseases

Age range

65 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rush University, Chicago, Illinois, United States

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About this study

Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) is a Phase III randomized controlled trial designed to test the effects of a 3-year intervention of a hybrid of the Mediterranean and DASH diets, called MIND, on cognitive decline among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets. The proposed MIND diet is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant-based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetables and berries as well as food component servings that reflect the nutrition-dementia evidence. The trial will employ a parallel group design comparing the effects on cognitive outcomes of the MIND intervention diet plus mild caloric restriction for weight loss to the control diet, usual diet with mild caloric restriction for weight loss. Biological effects of the MIND diet will be assessed by measurement of brain macro- and micro-structural integrity in 300 randomly selected participants. Other biochemical markers will be assessed in the entire cohort of 600 participants, including: plasma Abeta 42/Abeta 40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and inflammation. In addition, the trial will examine potential effect mediators and modifiers by a number of cardiovascular risk factors, AD biomarkers, and biological mechanisms. The proposed study has two clinical sites, one in Chicago (Rush University) and one in Boston (Harvard University), and centralized laboratories for data coordinating and analyses (Brigham & Women's Hospital), neuroimaging analyses (Rush University), and specialized laboratories for tissue biochemical analyses.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • family history of dementia
  • BMI >=25
  • suboptimal diet

Exclusion criteria

  • heavy alcohol use
  • severe illness
  • cognitively impaired
  • psychiatric illness

Treatment and study plan

MIND diet

Behavioral

3-year dietary counseling to adhere to the MIND diet and for mild weight loss

Mild Weight Loss

Behavioral

3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss

Primary outcomes

  1. Change in global cognitive function (composite score)

    Time frame: 3 years

    Global cognitive function assessment is based on a battery of 12 cognitive tests [1. Word list Memory; 2. Word List Recall; 3. Word List Recognition; 4. Logical Memory (East Boston Story Immediate Recall); 5. Logical Memory (East Boston Story Delayed Recall); 6. Verbal Fluency; 7. Multilingual Naming Test; 8. Trail A; 9. Trail B; 10. Flanker Inhibitory Control; 11. Oral Symbol Digit Modalities Test; and 12. Pattern Comparison. Individual test scores will be summarized by calculating the z-score for each test based on the mean and standard deviation of the sample distribution - averaging z-scores across tests will yield a composite score for global cognitive function. Cognitive function will be assessed at the baseline, 6, 12, 24, and 36 months to determine the time-course of cognitive change.

  2. Change in specific cognitive domains

    Time frame: 3 years

    Change in specific cognitive domains: episodic memory, semantic memory, perceptual speed, and executive function

Secondary outcomes

  1. Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters)

    Time frame: 3 years

    Changes in brain MRI-derived normalized measures of total brain volume (cubic centimeters) and hippocampal volume (cubic centimeters) and white/gray matter, segmented gray matter regions, white matter lesions, and thickness of segmented cortical regions.

Other outcomes

  1. Exploratory aim 1: Incidence of cardiovascular disease

    Time frame: 3 years

    To evaluate the role of MIND diet on the risk of incident cardiovascular disease. Cardiovascular disease is defined as the presence of coronary heart disease, cerebrovascular disease, and/or heart failure.

  2. Exploratory aim 2a: Blood pressure

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of systolic and diastolic blood pressure (mmHg) from the baseline to 6, 12, 24, and 36 months

  3. Exploratory aim 2b: Total cholesterol

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of total cholesterol (mg/dL), in plasma from the baseline to 3 and 36 months.

  4. Exploratory aim 2c: Low-density lipoprotein (LDL)

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of LDL (mg/dL) in plasma from the baseline to 3 and 36 months.

  5. Exploratory aim 2d: High-density lipoprotein (HDL)

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of HDL (mg/dL) in plasma from the baseline to 3 and 36 months.

  6. Exploratory aim 2e: Hemoglobin A1c (HbA1c)

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of HbA1c levels in plasma from the baseline to 3 and 36 months.

  7. Exploratory aim 3: Plasma amyloid beta (Abeta)

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of plasma Abeta 40 (pg/ml), Abeta42 (pg/ml), and ratio Abeta40/Abeta42 from the baseline to 3 and 36 months.

  8. Exploratory aim 4a: C-Reactive Protein (CRP)

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of CRP (mg/L) levels in plasma from the baseline to 3 and 36 months.

  9. Exploratory aim 4b: Interleukin 6 (IL-6)

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of plasma IL-6 (pg/mL) from the baseline to 3 and 36 months.

  10. Exploratory aim 4c: Oxidized LDL

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of oxidized LDL (mg/dl) in plasma from the baseline to 3 and 36 months.

  11. Exploratory aim 4d: Estimated glomerular filtration rate (eGFR)

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of eGFR (mg/dL) from the baseline to 3 and 36 months.

  12. Exploratory aim 4e: Brain-derived neurotrophic factor

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of plasma Brain-derived neurotrophic factor (pg/mL) from the baseline to 3 and 36 months.

  13. Exploratory aim 4f: Adiponectin

    Time frame: 3 years

    To evaluate the role of MIND diet on the change of plasma adiponectin (mg/L) levels from the baseline to 3 and 36 months.

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Collaborators

  • Brigham and Women's Hospital
  • Harvard School of Public Health (HSPH)
  • National Institute on Aging (NIA)

Registry information

Official study title

MIND Diet Intervention to Prevent Alzheimer's Disease

Acronym: MIND

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 29, 2016
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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